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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number TB-0535FC
Device Problems Pad (900); Break (1069); Thermal Decomposition of Device (1071); Component Missing (2306); Split (2537); Tip (3123)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/05/2017
Event Type  Malfunction  
Event Description

Operative note: name of operation: laparoscopic supracervical hysterectomy, cystoscopy. Description of operation: during the amputation, the thunderbeat broke. The first probe broke, which was replaced, the broken piece was visualized and removed. No malfunction of the equipment but only the tip broke off the disposable and was immediately retrieved. Equipment was sent to biomed to be checked and was cleared and returned to service. Disposable instrument with broken tip sent to manufacturer for analysis of defect. Olympus thunderbeat cut and seal device item# tb-0535fc lot# mk-658018. Letter from olympus: "probe broke off during a hysterectomy procedure" the tb-0535fc device was returned to olympus service center for a physical device evaluation. Olympus confirmed that the tip of the probe was broken off, and that the teflon pad was also damaged. The device was attached to the test generator and failed the probe check. Visual inspection found that about 45% of the teflon pad was missing, with the remainder burnt and split off. The metal below the teflon pad was exposed. Based on similar reports, a probable cause for the damage is operator's technique. The instruction manual contains several warning statements to prevent mechanical and thermal damage to the probe and teflon pad: "do not activate output while grasping hard tissue such as bone or highly calcified tissue, or hard objects. " "do not activate output while applying the probe tip to the tissue with a strong force, grasping thick tissue, positioning the tissue, twisting the shaft, or rotating the rotation knob. " "do not activate output while the grasping section is closed without contacting tissue or vessel, or ensuring that tissue is transected. Otherwise, a local increase of the temperature due to a friction between the probe tip and the grasping section may result in various forms of damage". If you have any questions regarding this matter, or if we may be of further assistance, please contact regulatory affairs, or your local olympus representative.

 
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Brand NameTHUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP
Type of DeviceUNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
3500 corporate pkwy
center valley PA 18034
MDR Report Key7468118
MDR Text Key106732156
Report Number7468118
Device Sequence Number1
Product Code KNS
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/24/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/27/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator UNKNOWN
Device MODEL NumberTB-0535FC
Device LOT NumberMK-658018
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/24/2018
Event Location Hospital
Date Report TO Manufacturer04/24/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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